Company OverviewStart Up Pharma company at Phase 3 Clinical Trial. Dynamic and very high potential startup environment.Role SummarySenior Quality Leader responsible for GMP oversight of a global external manufacturing network supporting late‑stage clinical development and preparation for regulatory submissions. Provides onsite quality leadership at CDMOs, ensuring compliance with GMP requirements, inspection readiness, and successful execution of registrational manufacturing activities.Key ResponsibilitiesServe as the onsite QA lead during manufacturing campaigns, providing quality decision‑making and issue resolution.Review and approve batch documentation, investigations, and analytical data to support batch release and regulatory filings.Partner with Qualified Persons (QPs) to support certification activities and ensure inspection‑ready documentation.Oversee deviations, OOS/OOT investigations, root cause analyses, and CAPA implementation.Provide QA oversight for technology transfer, process validation (PPQ), scale‑up, and commercial readiness activities.Manage GMP change controls and assess regulatory impact across manufacturing and testing operations.Collaborate with Technical Operations, Regulatory Affairs, and Supply Chain to support program execution, risk management, and quality strategy.TravelApproximately 50%+ (Europe and Asia).Required QualificationsBachelor’s degree in Life Sciences, Chemistry, Engineering, or a related discipline; advanced degree preferred.12+ years of GMP Quality Operations experience within the pharmaceutical or biotechnology industry.Strong experience supporting Phase 2/3 clinical programs, registrational manufacturing, and NDA/MAA readiness.Demonstrated expertise in CDMO oversight, GMP compliance, validation, and inspection preparedness.Experience with small‑molecule drug substance and drug product manufacturing.Knowledge of sterile injectable and solid oral dosage form manufacturing.Experience with drug‑device combination products is an advantage.Key CompetenciesLeadership and stakeholder management.Quality systems and compliance expertise.Investigation and problem‑solving skills.Regulatory inspection readiness.Cross‑functional collaboration.Ability to influence and make quality decisions in complex manufacturing environments.
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